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Comparison of Optical Coherence Tomography-derived Minimal Lumen Area, Invasive Fractional Flow Reserve and FFRCT

RecruitingNAAges 18 Years - anyAllInsel Gruppe AG, University Hospital Bern
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In plain words

What the trial is, and whether it could suit you

Significant left main (LM) stenosis is associated with a poor prognosis, therefore, adequate judgement of the prognostic significance of LM stenosis is essential to improve patients' prognosis. Recently, fractional flow reserve (FFR) has become widespread practice and carries a Class Ia recommendation to assess functional significance of intermediate coronary stenosis in patients with stable angina. Intravascular ultrasound (IVUS)-derived minimum lumen area (MLA) represents an accurate measure to determine LM significance as shown in multiple studies, while optical coherence tomography (OCT) ,which is a novel intracoronary imaging method with a greater spatial resolution (15μm vs. 100μm), faster image acquisition and facilitated image interpretation, OCT derived-MLA has never been validated against FFR and accordingly, it is not mentioned in the current guidelines for myocardial revascul

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Unprotected LM lesion \[midshaft, and distal bifurcation (Medina 1,1,1 or 1,1,0 or 1,0,1 or 1,0,0)\] of 30% to 80% angiographic diameter stenosis (DS) on visual estimation or equivocal disease by angiography. * Age ≥18 years. * Ability to give preliminary oral consent witnessed by an independent physician or sign written informed consent prior to any study-specific procedures. Exclusion Criteria: * Significant distal lesions (\>50% angiographic DS on visual estimation within the left anterior descending artery \[LAD\] or left circumflex artery \[LCX\], except for ostium of LAD or LCX or diseased side branch \[e.g. diagonal branch, obtuse marginal branch\]) * Ostial LM disease. * Acute coronary syndrome (ACS) (non-ST-elevation ACS and ST-elevation MI). * LM In-stent restenosis. * Previous coronary stenting of the left coronary system. * Chronic total occlusion. * Previous coronary artery bypass graft. * Previous MI related to the left coronary artery. * Occurrence of ventricularization or hypotension during engagement of the LM ostial lesion. * The presence of hemodynamic instability. * Known renal insufficiency (serum creatinine \>1.5mg/dL or receiving dialysis). * Female of childbearing potential (age \<50 years and last menstruation within the last 12 months), who did not undergo tubal ligation, ovariectomy or hysterectomy. * Life expectancy less than 1 year. * Contraindication or known allergy against protocol-required medications including heparin, iodinated contrast, β-blocker, nitroglycerin, and adenosine. * Body mass index \>35kg/m2. * Complex congenital heart disease other than anomalous coronary origins alone. * Ventricular septal defect.
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What it tests

  • OCT, FFR, CTA and FFRCT
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Where

13 sites
Centre Hospitalier Universitaire de Clermont-Ferrand
Clermont-Ferrand, France
Institute Mutualiste Montsouris
Paris, France
Centre Cardiologique du Nord
Saint-Denis, France
Universitätsklinikum Giessen Justus-Liebig Universität
Giessen, Germany
Friedrich Alexander Universität (FAU) , Medizinische Klinik 2 , Kardiologie und Angiologie
Erlangen, Germany
Ageo Central General Hospital
Ageo, Japan
Gifu heart center
Gifu, Japan
Department of Cardiovascular Medicine Shinshu University School of Medicine
Nagano, Japan

…and 5 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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